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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04763408




Registration number
NCT04763408
Ethics application status
Date submitted
17/02/2021
Date registered
21/02/2021
Date last updated
18/07/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
Scientific title
A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
Secondary ID [1] 0 0
E7080-M000-508
Universal Trial Number (UTN)
Trial acronym
STELLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Lenvatinib
Treatment: Drugs - Sorafenib

Lenvatinib - Participants with advanced or unresectable HCC will initiate treatment with lenvatinib capsules based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.

Sorafenib - Participants with advanced or unresectable HCC will initiate treatment with sorafenib tablets based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.


Treatment: Drugs: Lenvatinib
Oral capsules.

Treatment: Drugs: Sorafenib
Oral tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
Timepoint [1] 0 0
Up to 7 years
Primary outcome [2] 0 0
Number of Participants With SAEs With Lenvatinib
Timepoint [2] 0 0
Up to 7 years
Primary outcome [3] 0 0
Number of Participants With Grade 3 to 5 AEs With Lenvatinib
Timepoint [3] 0 0
Up to 7 years
Primary outcome [4] 0 0
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib
Timepoint [4] 0 0
Up to 7 years
Secondary outcome [1] 0 0
Duration of Lenvatinib and Sorafenib Treatment
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [2] 0 0
Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [3] 0 0
Relative Dose Intensity of Lenvatinib and Sorafenib
Timepoint [3] 0 0
Up to 7 years
Secondary outcome [4] 0 0
Overall Survival (OS) For Lenvatinib and Sorafenib
Timepoint [4] 0 0
Up to 7 years
Secondary outcome [5] 0 0
Number of Participants With Dose Interruption and Dose Reduction for Sorafenib
Timepoint [5] 0 0
Up to 7 years
Secondary outcome [6] 0 0
Number of Participants With Hepatotoxicity TEAEs With Sorafenib
Timepoint [6] 0 0
Up to 7 years
Secondary outcome [7] 0 0
Number of Participants With SAEs With Sorafenib
Timepoint [7] 0 0
Up to 7 years
Secondary outcome [8] 0 0
Number of Participants With Grade 3 to 5 AEs With Sorafenib
Timepoint [8] 0 0
Up to 7 years
Secondary outcome [9] 0 0
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib
Timepoint [9] 0 0
Up to 7 years

Eligibility
Key inclusion criteria
1. Participants with advanced or unresectable HCC for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label
2. Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2023
Sample size
Target
Accrual to date
Final
335
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
1871 - Liverpool
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Austria
State/province [4] 0 0
Tirol
Country [5] 0 0
Austria
State/province [5] 0 0
Klagenfurt Am Woerthersee
Country [6] 0 0
Austria
State/province [6] 0 0
St. Pölten
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Germany
State/province [8] 0 0
Nordrhein-Westfalen
Country [9] 0 0
Germany
State/province [9] 0 0
Rheinland-Pfalz
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Munich
Country [12] 0 0
Germany
State/province [12] 0 0
Ulm
Country [13] 0 0
Italy
State/province [13] 0 0
Campania
Country [14] 0 0
Italy
State/province [14] 0 0
Lazio
Country [15] 0 0
Italy
State/province [15] 0 0
Sardegna
Country [16] 0 0
Italy
State/province [16] 0 0
Bologna
Country [17] 0 0
Portugal
State/province [17] 0 0
Setúbal
Country [18] 0 0
Portugal
State/province [18] 0 0
Coimbra
Country [19] 0 0
Portugal
State/province [19] 0 0
Lisboa
Country [20] 0 0
Portugal
State/province [20] 0 0
Vila Real
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Chuvashskaya Respublika
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Cantabria
Country [24] 0 0
Spain
State/province [24] 0 0
Murcia
Country [25] 0 0
Spain
State/province [25] 0 0
Alicante
Country [26] 0 0
Spain
State/province [26] 0 0
Córdoba
Country [27] 0 0
Spain
State/province [27] 0 0
Getafe
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Málaga
Country [30] 0 0
Spain
State/province [30] 0 0
Santiago de Compostela
Country [31] 0 0
Spain
State/province [31] 0 0
Sevilla
Country [32] 0 0
Spain
State/province [32] 0 0
Valencia
Country [33] 0 0
Spain
State/province [33] 0 0
Zaragoza
Country [34] 0 0
Sweden
State/province [34] 0 0
Stockholm
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Birmingham
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events \[SAEs\], grade 3 to 5 adverse events \[AEs\], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.
Trial website
https://clinicaltrials.gov/study/NCT04763408
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04763408